Heart DiseasesECHOGERNCT06445231
Echocardiography in Nursing Home
A study testing Implementation of echocardiography in nursing homes in people with Heart Diseases and Heart Failure, run by Nantes University Hospital at 1 site in France.
Trial summary
The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases, Heart Failure, Heart Valve Diseases
- What is being tested?
- Implementation of echocardiography in nursing homes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2024to 2 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Nursing homes residents with a life-expectancy estimated > 1 year, and able to participate to the study, giving an oral consent
Who cannot join
- no accessible to echocardiography
- closed unit (severe Alzheimer disease…)
- recent contagious disease such Covid (<15 days)
- no consent to participate
- no social security number
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Thierry LE TOURNEAU, PU-PH, 33 2 40 16 54 98, thierry.letourneau@chu-nantes.fr
Anne-Sophie BOUREAU, PH, 33 2 40 16 85 35, annesophie.boureau@chu-nantes.fr
About this study
Official title: Implementation and Effectiveness of Screening Echocardiography Performed in Nursing Home: ECHOGER
The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.
Read the detailed description
Open-label cluster randomized type 1 hybrid trial, with 2 parallel arms: nursing homes will be randomized in the interventional (echocardiography by sonographer) or non-interventional arms (usual care). In the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline. Clinical management will be adapted to the result of echocardiography by the general practitioner, in accordance with the cardiologist. The main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology. The Primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months.
Thirty nursing homes and 1050 residents will be included overall
- Conditions
- Heart Diseases, Heart Failure, Heart Valve Diseases
- Being tested
- Implementation of echocardiography in nursing homes
- Keywords
- Echocardiography, Nursing Home, Implementation, Heart Failure
- Medical subject headings
- Heart Diseases, Heart Failure, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of echocardiography in nursing homesDiagnostic test
An ultrasound will be carried out in the EHPAD, the result of which will be interpreted by a cardiologist then sent to the establishment and the attending physician with instructions to follow.
| Study group | Role | What they receive |
|---|---|---|
| Echocardiographic screening arm | Experimental | Participants from nursing homes allocated to echocardiographic screening group will benefit of one echocardiography at inclusion. Receives: Diagnostic Test: Implementation of echocardiography in nursing homes |
| Usual care | No intervention | Participants from nursing homes allocated to no-screening group. Participants will be followed for medical management and care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of resident presenting a heart failure decompensation
Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure
Measured: 12 months
Secondary outcomes (1)
Presence of a clinically significative change in medical management and care in the month following ultrasound
A binary outcome will be constructed, based on the following algorithm: clinically significative change set to "yes" if a change in ongoing drug prescription is observed, and/or a cardiologist visit is planned, and/or a geriatrist visit is planned, and/or an hospitalization for clinical work-up is set, and/or a resume of the ultrasound is sent to the GP. Otherwise (all components set to "absent"), this outcome will be set to "None".
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start2 Oct 2024
- Primary completion2 Oct 2028 (estimated)
- Study completion2 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Nursing home randomization in 1:1 ratio between echocardiography and no-echocardiography
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Directorate of Health Care Supply
- Responsible party
- Sponsor
- Investigators
- Thierry LE TOURNEAU, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445231
- Sponsor's protocol ID
- RC22_0449
- Acronym
- ECHOGER
- Status last verified
- Oct 2026
- First submitted
- 14 May 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Effectiveness of Screening Echocardiography Performed in Nursing Home: ECHOGER
- ClinicalTrials.gov ID
- NCT06445231
- Acronym / sponsor ID
- ECHOGER / RC22_0449
- Conditions
- Heart Diseases, Heart Failure, Heart Valve Diseases
- Keywords
- Echocardiography, Nursing Home, Implementation, Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Directorate of Health Care Supply
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 2 Oct 2028 (estimated)
- Study completion
- 2 Oct 2030 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.
Detailed description
Open-label cluster randomized type 1 hybrid trial, with 2 parallel arms: nursing homes will be randomized in the interventional (echocardiography by sonographer) or non-interventional arms (usual care). In the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline. Clinical management will be adapted to the result of echocardiography by the general practitioner, in accordance with the cardiologist. The main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology. The Primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months.
Thirty nursing homes and 1050 residents will be included overall
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nursing home randomization in 1:1 ratio between echocardiography and no-echocardiography
| Arm | Type | Receives |
|---|---|---|
| Echocardiographic screening arm | Experimental | Diagnostic Test: Implementation of echocardiography in nursing homesParticipants from nursing homes allocated to echocardiographic screening group will benefit of one echocardiography at inclusion. |
| Usual care | No intervention | –Participants from nursing homes allocated to no-screening group. Participants will be followed for medical management and care as usual. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Nursing homes residents with a life-expectancy estimated > 1 year, and able to participate to the study, giving an oral consent
Key exclusion criteria (5 listed)
- no accessible to echocardiography
- closed unit (severe Alzheimer disease…)
- recent contagious disease such Covid (<15 days)
- no consent to participate
- no social security number
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of echocardiography in nursing homesAn ultrasound will be carried out in the EHPAD, the result of which will be interpreted by a cardiologist then sent to the establishment and the attending physician with instructions to follow. | Diagnostic test | Echocardiographic screening arm |
Primary outcome
Count of resident presenting a heart failure decompensation
Time frame: 12 months
Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure
1 secondary outcome
Presence of a clinically significative change in medical management and care in the month following ultrasound
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thierry LE TOURNEAU, PU-PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of echocardiography in nursing homes in people with Heart Diseases and Heart Failure, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry LE TOURNEAU, PU-PH (33 2 40 16 54 98, thierry.letourneau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of resident presenting a heart failure decompensation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.